IA #66-64 - 3/12/97, "Detention Without Physical Examination and Surveillance
of Essiac and Products Containing Essiac", ATTACHMENT 3/25/08
SUBJECT : ***Detention Without Physical Examination ***
and Surveillance of Essiac and Products Containing Essiac
TYPE OF ALERT : ***Detention Without Physical Examination***
Surveillance
Note: This alert is being revised to provide changes to format and/or
terminology and are bracketed by asterisks (***)
***(NOTE: This import alert contains guidance to FDA field
personnel only. It does not establish any requirements, or create
any rights or obligations on FDA or on regulated entities.)***
PRODUCT : Essiac and products containing Essiac, such as herbal teas
and drinks, *PROMOTED AS A DRUG IN THE TREATMENT OF
CANCER*. (*capitalized for added emphasis)
PRODUCT CODE : 66[][][][][]
PROBLEM : New Drug without an approved New Drug Applicaton
(NDA)-(DRND)
PAC FOR
COLLECTION : 56008H
COUNTRY : See Attachment
MANUFACTURER/
SHIPPER : See Attachment
MANUFACTURER/
SHIPPER ID : See Attachment
IMPORTER'S ID : N/A
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be a new drug within the meaning of Section
201(p) without an approved New Drug Application
(NDA)[Unapproved New Drug, Section 505(a)]."
RECOMMENDING
OFFICE : Buffalo District
REASON FOR ALERT : In March 1994, BUF-DO conducted an inspection of
a distributor in Buffalo, NY, as a follow-up to
a consumer complaint alleging Essiac Tea was
being promoted as a cancer treatment. The
inspection revealed that the firm takes 2 oz.
bags of tea labeled as "CAISSE'S HERBAL TEA" and
provides various literature, which accompanies
the tea, indicating that it is effective in
treating cancer.
The Caisse's Herbal Tea is blended and repacked at Organic
Connections, Wainfleet, Ontario, Canada and brought into
the U.S. by the vice president of the Buffalo
distributorship, who also operates a similar business from
a residence in Canada. The firm in Canada does business
as New Action Products, P.O. Box 141, Sunnylea Crescent,
Grimsby, Ontario.
Ingredients listed on the 2 oz. package include burdock
root, sheep sorrel, slippery elm bark, and turkey rhubarb
root. Two booklets entitled "ESSIAC" and "I Was Canada's
Cancer Nurse; The Story of ESSIAC by Rene M. Caisse,
R.N.," accompany the product. The literature describes
an herbal mixture known as "Essiac" discovered by a
Canadian nurse, Ms. Rene M. Caisse. Essiac is Caisse
spelled backwards.
Essiac has been touted as a treatment for cancer and more
recently for AIDS. Studies performed on the preparation of
Essiac in Canada and by the National Cancer Institute
found that the product had no anti-tumor activity.
Moreover, this product is not the subject of an approved
NDA.
GUIDANCE : ***Districts may detain, without physical examination,***
Caisse's herbal tea, Essiac, or products containing
Essiac, from the manufacturers listed on the Attachment.
Continued surveillance of herbal teas and preparations
from other Canadian firms is warranted.
When districts encounter shipments of these products that
may be considerd new drugs without an approved new drug
application (NDA) because of label claims or accompanying
literature, the information, *INCLUDING ALL ACCOMPANYING
LABELING CONTAINING DRUG CLAIMS TO SUPPORT THE 505(A)
CHARGE*, should be forwarded to DIOP, HFC-170, for review
by CDER for possible incorporation into the Attachment to
this alert. (*capitalized for added emphasis)
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required
KEYWORDS : Essiac, Caisse, herbal tea, tea, herbs
ATTACHMENT IA #66-64 3/25/08
FIRMS/PRODUCTS UNDER DETENTION WITHOUT PHYSICAL EXAMINATION
CANADA (CA, 260)
Mfr/Shipper: Product:
Organic Connections CAISSE'S HERBAL TEA
P.O.Box 78 (shipped as kit)
Wainfleet, Ontario, L0S 1V0
MID #XOORGCON78WAI
New Action Products (Same as above)
P.O. Bx 141
Grimsby, Ontario, L3M 4G5
MID #XONEWACT141GRI
New Action Products (Same as above)
8 Waterloo Street
Fort Erie, Ontario
MID #XONEWACT8FOR
New Action Products (Same as above)
10 Sunnylea Crescent
Grimsby, Ontario
MID #XONEWACT10GRI
Easy-Ac EASY-AC
Box 20111
Rideau Street
Ottawa, Ontario K1N 9N5
MID #XOEASAC2011OTT
Essiac International ESSIAC
2211-1081 Ambleside Drive
Ottawa, Ontario K2B 8L8
MID #XOESSINT2211OTT
Essiac Canada International Essiac Extract
164 Richmond Rd. 66V[][]99
Ottawa, Canada K1Z6W2 08/11/06
FEI# 3004110621
Essiac Canada International Essiac Extract
P.O. Box 23155 66V[][]99
Ottawa, Canada K2A 4E2 08/11/06
FEI # 3004796236
Everest Foods ESSIAC POWDER
Unit 407, 10 Caxton Close 2/2/96
Halifax, Nova Scotia B3M 4J7
Canada
MID# XNEVEFOO407HAL
Flora Manufacturing & Distributing Ltd. FLOR-ESSENCE
7400 Fraser Park Road
Burnaby, British Columbia V3J 5B9
MID #XCFLOMAN7400BUR
Enrich International NATIVE LEGEND TEA
(Summerland, British Columbia)
MID #XCENRINTSUM
The Herb House ESSIAC
3232 Eglinton Avenue
Scarborough, Ontario
MID #XOHERHOU3232SCA
Essiac Products, Inc. ESSIAC
4 Howard Avenue 66V99, 54E99, 54F08, 54F99
Campbellton, New Brunswick 54Y99, 31K99, 31P99
FEI #3000222866
Eddy's Herbs Burdock Blend Capsules
aka Go Print Inc. Product Codes: 31K99
3 King Street 31P99, 54E99, 54F08,
P.O. Box 938 54F99, 54Y99, 66V99
St. Catharines, Ontario L2R 6Z4 12/5/95
FEI# 1000450758 (Eddy's Herbs)
FEI# 1000450759 (Go Print Inc.)
Pearl E. Bally Canadian Native Tea/
11 Bayside Private 66V--99
Ottawa, Ontario K1V 9R3
Canada
MID# XOPEABAL11OTT
FEI# 1000556466
Wellness Pharmacy Essiac
884 Portage Avenue 66V99, 54E99, 54F08,
Winnipeg, Manitoba R3G 0P1 54F99, 54Y99, 31K99,
FEI# 3000222865 31P99
3/12/97
|
